MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 8900

Device Problem Failure to Zero (1683)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2019

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the comet was returned and analysis was completed.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed two kinks.The first kink was located 38cm from the tip.The second kink was located 177cm from the tip.There was tip damage noticed.There was peeled coating at the 177cm location.The wire was connected to the returned occ handle.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.A known good occ handle was used to verify cable operation was correct with the returned occ.The test occ cable and the connected returned wire functioned as designed.The returned cable was dissected to check for damage.It was noticed that the fep disk was damaged where the wire seats against the disk.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed 14 nov 2019.It was reported that the comet pressure had been unable to be recognized by the ffr link.Another comet was used to complete the procedure without issue.However, the returned device analysis revealed some slight peeling of the device coating.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9378721
• MDR Text Key: 173949495
• Report Number: 2134265-2019-14052
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023099681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1